[Next-Generation Sequencing Book]
  • [Photo] Jessica Cartmel • December 23, 2008

    BACKGROUND

    Shape Your Future And Ours. Schering-Plough is an innovation-driven, science-centered global health care company. Through our own biopharmaceutical research and collaborations with partners, we create therapies that help save and improve lives around the world. We apply our research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by our colleagues around the world.

    RESPONSIBILITIES

    The Associate Director, Global Clinical Audits is responsible for the implementation of the GCP quality assurance audit program for his/her region based upon the GCA global audit strategy. With oversight from the Departmental Head and close interactions with other regional GCA audit units, directs the planning and conduct of good clinical practice (GCP) quality assurance audits according to the GCP audit program. Identifies and allocates adequate resources for the conduct of audits and evaluations. Reviews and evaluates audit results for adequacy and assessment of the GCP unit training needs. Develops monitoring of the audit program performance and identifies opportunities for audit program improvement and participates in development of Global Clinical Audits audit procedures. Applies advanced technical skills in GCPs. Provides quality and compliance guidance to client groups. Identifies trends in compliance issues and provides periodic feedback to management.

    REQUIREMENTS

    • Science degree required, advanced degree preferred in medical or life science discipline
    • Minimum 8 years clinical research and development experience in pharmaceutical industry
    • Minimum 5 years of GCP compliance experience
    • Must have a thorough understanding of applicable global regulations/guidelines to facilitate the interpretation and impact of compliance concerns of internal and external audits
    • Must be willing to travel worldwide, approximately 25%
    • Experience in working with and understanding different cultures
    • Minimum 3 years of management experience
    • Strong analytical and interpersonal skills are required as well as excellent written and verbal communication skills
    • Must be able to build strong relationship network within the Clinical Research and Operations organization to help with the identification of potential issues and prioritization of the audit activities
    Education: Master's Degree
    Experience: Over 10 Years

    ARTICLE

    Public ID: 23518BR
    External ID: 926101

    TERMS

    Type: Full Time
    Duration: Permanent

    SALARY & COMPENSATION: Commensurate

    HOW TO APPLY

    Please copy and paste the following link into your browser address bar:
    http://appclix.postmasterlx.com/track.html?pid=402881bd1e48ea6f011e4b88058e05d2&source=bioinformatics

    Schering-Plough is an equal opportunity employer. M/F/D/V

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